Making a complaint about UK Government services The Parliamentary Ombudsman can carry out independent investigations into complaints about government departments and other public organisations. We would normally expect that the organisation you are complaining about has had the opportunity to respond to your concerns. This form is to help us decide if we can look at your complaint. We need specific information from you so that we can deal with your complaint as quickly as possible. If we feel that we do not understand your complaint, then we may return the form to you to be completed before we take any action on your complaint. To help us consider your complaint, we need to see all the evidence that you have about it in particular letters to and from the organisation you are complaining about. We are happy to copy originals and return them to you. You will need an MP to sign Section 9 of this form. If you are unable to fill in the form or you need any advice, you can contact our helpline on 0345 015 4033. The helpline is open from 8:30am to 5:30pm Monday to Friday, excluding public holidays.
SECTION 1: About you If you are complaining on behalf of someone else then they must complete Section 7 of this form if they are able to. 1. About you: PIP Action Campaign group complaint EN- 165739 Name: Address: Postcode: Telephone number: Email: pip.action.campaign@gmail.com How and when would you prefer to be contacted? By email cc via pip.action.campaign@gmail.com Do you have any special requirements for us to communicate with you? We will make adjustments for you if we can. Please copy me into all relevant correspondence with PIP Action Campaign Are you being supported by an advocacy organisation or other representative? Please provide their details if you would like us to copy them into our correspondence. I wish to join PIP Action Campaign group complaint as a victim of the PIP Breast Implant fraud. Well keep in touch with you in whichever way works best for you. However, we do need to make you aware that with email there is always a small risk of messages being intercepted. If this is your preferred way for us to contact you please let us know by ticking one of the boxes below. As a precaution, and for added peace of mind, we will also password protect any sensitive documents we send you. To confirm you are content for us to email you, please tick this box x If you do not want us to correspond with you by email, please tick this box
2. Is the complaint on behalf of someone else? YES / NO If you have answered YES to this question, please also complete questions 3 and 4. If you have answered NO to this question, please go to question 5. 3. Who are you complaining on behalf of: N/A Name: Address: Postcode: Telephone number: What is your relationship to them? If the person has died, please tell us the date of death here: 4. Please explain why the person who has suffered as a result of the problem is not making the complaint. We would normally expect a person to make their own complaint if they are able to. However, you can represent someone to make a complaint if you have their consent. Efforts to resolve the issues have failed and the complaints procedures have been exhausted by PIP Action Campaign on my behalf. I wish my complaint to be included as part of the PIP Action Campaign complaint. SECTION 2: Information about the organisation that you are complaining about You can contact us before filling in this form if you are not sure whether your complaint is about an organisation we can consider. Our helpline number is 0345 015 4033. 5. Which organisation(s) are you complaining about? Department of Health, authors of government reviews and MHRA
SECTION 3: Your complaint We need to know what happened and why you are unhappy with the response to your complaint. Please attach additional sheets of paper if you need more room to set out correspondence. If the organisation has not addressed all of the issues raised in your complaint, then we may decide that there is further work for the organisation to do before we look at your concerns. 6. Please briefly explain what your complaint is about: Our complaint against the DoH and the MHRA is for dereliction of duty and gross negligence, outlined as follows: DoH and MHRA have failed in their duties and responsibilities to respond to a national health crisis. The government commissioned Reports & Reviews from DoH and MHRA, which rely on flawed and inaccurate data detrimental to the victims. MHRA ignored recommendations to broaden the scope and nature of the available evidence Both Agencies failed to publish, scrutinize or question self- referenced data MHRA acted in the interests of industry, failing in its duties & responsibilities to the public MHRA failed to monitor victims or conduct adequate testing & collect data MHRA failed to communicate with international regulators and act on their concerns Both agencies fail to update clinical and treatment guidelines and fail to keep Drs, surgeons and victims informed of newly emerging evidence. Failed to declare Conflicts of Interests Perverting the evidence & truth 7. Why are you still unhappy following the response(s) from the organisation(s)? Both organisations are failing to review the available evidence, revise guidance, recommend appropriate treatment and offer future monitoring. Victims being denied access to NHS services, appropriate diagnostics, treatment options for best possible outcome. Psychological needs of patients ignored. Victims suffering prolonged. 8. Has the organisation responded to all the issues raised in your complaint? If the answer to this question is NO, then please set out below the issues that have not been addressed. 1. Reliance on flawed, inaccurate & irrelevant Data 2. Review of clinical findings and emerging evidence 3. Guidance to breast feeding & pregnant mothers 4. Conflict of Interests of advisors & experts 5. Review guidance for treatment to healthcare professionals 6. Lack of testing & data collection 7. Lack of European & international co- operation 8. Hindering access to NHS healthcare services by victims
9. Failure to treat, care and monitor victims 10. are, serving the medical devices industry. 11. Allowing industry to participate in evidence gathering and policy decisions while knowingly preparing to liquidate & asset strip to avoid liabilities. 12. Increasing VAT on corrective surgeries to fraud victims in need of corrective surgeries. 13. Failure to initiate criminal investigations into PIP fraud 14. Prolonging victims exposure to and danger from PIP 9. How have you been affected by what happened? (If you need more space attach additional pages) SECTION 4: Outcome Examples of remedies we regularly achieve are apologies, improvements to services, and financial payments. 10. What outcome(s) do you want us to achieve for you? Urgent change to care, treatment and monitoring guidelines On- going bio- monitoring and testing for all those affected including children Data banks, clinical reports and research Victim support Reimbursement of costs associated with fraud and of corrective surgeries Compensation for damages 11. If you are seeking a financial remedy, what would be a reasonable sum of money to remedy your complaint? A reasonable sum as compensation for damages, harm to health and reimbursement of costs would be a figure between 35,000 and 100,000
SECTION 5: When things happened The law says that a complaint should be made to an MP within a year of you becoming aware there is a problem. We can extend this time limit but only where there are special circumstances. 12. When did the events occur? From June 2012 13. When were you aware there was a problem and when did you complain? I was alerted to concerns in the media and the probable consequences of fraudulently manufactured breast implants. PIP Action Campaign made its first contact with the Department of Health in response to the Keogh Expert Final Review June 2012 14. If you did not complain straight away, please explain why: _N/A 15. When did you first write to your MP about your complaint? EN- 165739 16. If there was more than a year between you becoming aware of the problem and you contacting your MP, please explain why you did not complain to your MP earlier. It would be helpful if you could provide relevant dates of when key events happened. For example, the date of your in responses. N/A 17. If there is a long time between any of the above dates, please explain what was happening. N/A
SECTION 6: Legal action The law says that we must consider whether it is reasonable for you to pursue legal action to achieve the outcomes you are seeking. We may not be able to look at your complaint: if you are already pursuing legal action; or are planning to take legal action; or if we consider that there is a course of legal action open to you that is reasonable for you to pursue. 18. Are you taking, or planning to take, legal action on your complaint? If YES please give details. Please advise urgently if you consider there is a course of legal action open to me that is reasonable for me to pursue. SECTION 7: Authorisation I wish the Ombudsman to investigate my complaint and I consent to the obtaining of all relevant papers for the purposes of investigating a complaint under the Parliamentary Commissioner Act 1967. Signature: Date: I give my consent for a complaint to be made on my behalf and for the Ombudsman to obtain all relevant papers for the purposes of investigating a complaint under the Parliamentary Commissioner Act 1967. I understand that this may mean that my representative will be able to access personal information obtained for the investigation. Signature: Date:
SECTION 8: To the MP This section must be completed by the person making the complaint To (Name of MP) EN- 165739 MP House of Commons, London SW1A 0AA Please consider the complaint described on this form and in any information attached. Please complete section 9 and send this complaint to the Parliamentary Ombudsman.
SECTION 9: From the MP to the Ombudsman This section must be completed by the MP EN- 165739 To: The Parliamentary Ombudsman, Millbank Tower, Millbank, London SW1P 4QP Mr/Mrs/Miss/Ms Has sent me a complaint. Please consider this complaint and let me know the outcome. Signature of MP: Print name: Date:
Parliamentary and Health Service Ombudsman Millbank Tower Millbank London SW1P 4QP Enquiries: 0345 015 4033 Fax: 0300 061 4000 Email: phso.enquiries@ombudsman.org.uk www.ombudsman.org.uk